Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure

NCT06991010 | Not Yet Recruiting FDA Device

• 1 other identifier: TT012025
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multicenter study intended to provide supportive clinical information on the use of the SAPH device to achieve radial artery patent hemostasis after a transradial procedure.

Conditions

Hemostasis of Arterial Punctures

Keywords

Artery clamp; Transradial access; Radial artery patency; Radial artery hemostasis

Outcome Measures

Primary Outcomes (2)

• Efficacy Endpoint - Percent of subjects with radial artery hemostasis with patency at time of discharge

  Radial artery hemostasis with patency is defined as hemostasis over the arterial puncture site with palpable distal radial pulse or prominent digital arterial waveform signal by digital plethysmography with ulnar occlusion.

  60 minutes prior to same-day discharge or within 24 hours post-TRA procedure.

• Safety Endpoints - 1) Percentage of subjects with radial artery patency 2) No major device-related access site-related complications prior to discharge

  Patency is defined as prominent digital arterial waveform signal by digital plethysmography with ulnar artery occlusion.

  60 minutes prior to same-day discharge or within 24 hours post-TRA procedure

Study Arms (1)

SAPH Device

EXPERIMENTAL

All patients who have the SAPH device used to achieve hemostasis

Device: Suction-Activated Patent Hemostasis (SAPH) Device

Interventions

Suction-Activated Patent Hemostasis (SAPH) Device DEVICE

A compression device intended to achieve patient hemostasis of the radial artery

SAPH Device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 21 years or older.
• Patient is scheduled to undergo a coronary or peripheral catheterization procedure requiring 5 or 6 Fr transradial sheath access (TRA) with planned same-day discharge
• Patient has a Reverse Barbeau test result of Type A, B or C (patent radial artery)
• Patient is able to understand informed consent language
• Patient is willing and able to sign informed consent and adhere to the protocol requirements

You may not qualify if:

• Patient had a prior ipsilateral TRA procedure
• Patient has scleroderma, vasculitis, or Raynaud's syndrome (primary or secondary)
• Patient has cellulitis overlying radial artery
• Patient requires uninterrupted oral systemic anticoagulation
• Patient has intolerance to standard anticoagulants used in TRA procedures
• Patient has non-palpable radial pulse or Reverse Barbeau test Type D response
• Patient is participating in another investigational study
• Patient is a prisoner
• Patient, in the principal investigator's opinion, would not be able to comply with protocol requirements including self-report of comfort and 30-day follow up
• Patient is receiving glycoprotein IIb/IIIa inhibitors
• Patients with allergy to medical adhesives

Sponsors & Collaborators

• Transradial Technologies, LLC: lead
• RARAS CRO: collaborator

Study Officials

• Regulatory and Clinical Lead, PhD

  Transradial Technologies, LLC

  STUDY DIRECTOR

Central Study Contacts

Regulatory and Clinical Lead

CONTACT

908-420-2707; jvargo1@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, nonrandomized, single-cohort, interventional clinical study

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 25, 2025
• Study Start: August 1, 2025
• Primary Completion: October 28, 2025
• Study Completion: November 28, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07